Act as Lead Human Factors Engineer
Plan and execute Human Factors Engineering activities in drug delivery device projects, including development of secondary packaging and Instructions for Use
Set and drive best practices within DDS&P for Human Factors Engineering
Support standardization of approaches for Task Analysis, Use Risk Assessment, and other key deliverables
Lead HF oversight of secondary packaging development
Partner with project leads and the cross-functional development team on planning and execution of projects
Lead development of selection criteria and evaluation of the user interface for new products
Collect, maintain, and utilize data on user capabilities and known use problems with combination products
Contribute to the development of Company Core Data Sheets (CCDS)
Plan and execute Formative and Summative evaluations, including selection and oversight of CROs
Leverage existing data to support regulatory submissions, e.g., comparative analysis
Develop dossier submissions for HF content, including HFE/UE Report, and responses to regulatory agency questions
Monitor industry trends, standards, and regulatory guidance

Excellent communication skills and a track record working in a matrix environment
Ability to influence and promote a culture of continuous improvement
Subject Matter Expertise on: IEC 62366 family of standards and related regulatory guidance
User Capabilities – anthropometric basis
Use Risk Assessments
Proven track record of: Evaluation of user interfaces for drug delivery devices
Development of instructional materials for product labelling and artwork
Relevant academic qualification in an appropriate field, e.g., Ergonomics, Psychology or a suitable Science or Engineering degree
At least 8 years of related experience in the pharmaceutical or medical device industry
Ability to travel internationally up to 20%.

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are.
It fuels our innovation day in and day out.
By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

Senior Principal Engineer, Human Factors

Key skills